Kornimate/medical-research-clean huggingface dataset:
hepatitis c: community testing and treatment (ct2 study myanmar)

Conditions: Hepatitis C

Summary: implementation-effectiveness hybrid trial assessing acceptability, feasibility and cost-effectiveness of community-based point-of-care testing and treatment for hepatitis c. utilises cepheid genexpert hcv vl device as diagnostic tool (diagnosis of chronic infection and assessment of treatment outcome) and sofosbuvir/daclatasvir for hcv therapy (local standard of care).

historically, testing and treatment for hepatitis c has been confined to centralised laboratories and tertiary hospitals respectively. recent advancements in point-of-care testing for hepatitis c (anti-hcv antibody and hcv rna/vl) and treatment options with the introduction of direct acting antivirals allows for testing and treatment to occur in de-centralised primary care settings. this study is an effectiveness-implementation hybrid study to assess the feasibility, acceptability, effectiveness and cost-effectiveness of a de-centralised approach to hepatitis c testing and treatment at community-based clinics in yangon, myanmar. generalist doctors trained in hepatitis c treatment will prescribe direct acting antiviral therapy to eligible participants. the study will utilise sd bioline hcv rdt and cepheid genexpert hcv vl test; and sofosbuvir/daclatasvir to treat hepatitis c. test of cure will be performed at 12 weeks post-treatment completion to assess sustained virological response (svr). study inclusion criteria prior to recruitment into study: * aged ≥18 years * attendance at study site * willing and able to provide written informed consent study exclusion criteria prior to recruitment into study: * confirmed hcv rna positive result (chronic hcv infection) prior to study recruitment * treatment experienced (either daa or pegylated interferon) * hepatitis b virus (hbv) infected * human immunodeficiency virus (hiv) infected * estimated glomerular filtration rate (egfr) \<30 * active tuberculosis (if known active tuberculosis or as per symptom screening assessment) * pregnant women * serious drug-drug interaction with sofosbuvir/daclatasvir of a drug that the patient is unwilling or unable to stop taking

Eligibility criteria:
inclusion criteria: * aged ≥18 years * attendance at study site * willing and able to provide written informed consent exclusion criteria: * confirmed hcv rna positive result (chronic hcv infection) prior to study recruitment * treatment experienced (either daa or pegylated interferon) * hepatitis b virus (hbv) infected * human immunodeficiency virus (hiv) infected * estimated glomerular filtration rate (egfr) \<30 * active tuberculosis (if known active tuberculosis or as per symptom screening assessment) * pregnant women * serious drug-drug interaction with sofosbuvir/daclatasvir of a drug that the patient is unwilling or unable to stop taking

Keywords: hepatitis c myanmar primary care direct acting antivirals
vasopressin versus norepinephrine for the management of septic shock in cancer patients

Conditions: Septic Shock

Summary: although arginine vasopressin has been used as an additional drug in refractory shock in worldwide clinical practice, there are no prospective studies using it as a first choice therapy in patients with cancer and septic shock. the aim of this study is assess if the use of arginine vasopressin would be more effective on treatment of septic shock in cancer patients than norepinephrine, decreasing the composite end point of mortality and organ failure in 28 days.


Eligibility criteria:
inclusion criteria: * solid neoplasm needing icu * septic shock according standard criteria exclusion criteria: * younger than 18 years; * pregnancy; * raynaud's phenomenon, systemic sclerosis or vasospastic diathesis; * severe hyponatremia (na\<130meq/l); * acute mesenteric ischemia; * acute myocardial infarction; * cardiogenic shock; * current use of vasopressor before randomization * expected icu stay less than 24 hours * enrolled in another study; * refusal to consent.
impact of caregiver beliefs on adherence to antipsychotic medications in patients with schizophrenia

Conditions: DSM-5 Schizophrenia

Summary: only one third of patients with schizophrenia are observant to their treatment knowing that the lack of adherence to treatment is one of the most important predictors of relapse. recent work shows that the erroneous or negative beliefs of patients with schizophrenia regarding antipsychotic treatment are associated with poor compliance. the hypothesis is that negative beliefs about the antipsychotic treatment of caregivers of patients with schizophrenia may be associated with a higher risk of poor compliance compared to caregivers with positive beliefs about treatment. the primary purpose is to explore the correlation between caregiver beliefs about treatment and patient compliance, taking into account the level of caregiver-patient link.

non-interventional cross-sectional exploratory study with a single visit for patients with schizophrenia and their caregivers, who agreed to participate in the protocol.

Eligibility criteria:
inclusion criteria: * patient over 18 years old * with a diagnosis of schizophrenia according to dsm-5 criteria * accompanied by his main caregiver, who will be able to complete the questionnaires after having signed the information form. * treated with one or more antipsychotics. * able to complete the questionnaires related to the protocol * having agreed to sign the information form. exclusion criteria: * not understanding french, unable to answer questions linguistically * presenting an organic pathology and / or cognitive deterioration likely to hinder a good understanding of the interview * having already participated in the study * presenting disorders related to the use of substances of severe intensity (such as acute intoxication, withdrawal syndrome or any state of delirium)

Keywords: schizophrenia beliefs caregiver
comprehensive heart failure disease management community program

Conditions: Heart Failure

Summary: the purpose of this study is to determine whether a nurse-led, comprehensive disease management program is effective in reducing recurrent hospital admissions and deaths in community dwelling patients with moderate to severe heart failure.

heart failure remains a significant cause of death, in spite of recent declines in overall mortality from cardiovascular disease. heart failure is associated with increasing costs for healthcare, mainly for recurrent hospital admissions. disease management programs aimed to improve patients outcome while containing healthcare costs,were employed in heart failure patients with varying results. such programs contain various components, including patient education and empowerment, monitoring patients' adherence to therapy, telemonitoring of vital parameters, etc. designated heart failure clinics were also employed in care given to these patients.

Eligibility criteria:
inclusion criteria: 1. adult patients with nyha-stage iii-iv heart failure recruited in the community; 2. adult patients with nyha-stage ii-iv heart failure recruited after hospital admission for decompensated heart failure exclusion criteria: * other severe disease (e.g. end stage renal disease, metastatic cancer); bedridden or severely compromised functional status due to other diseases; drug or alcohol abuse; severe cognitive impairment; people unconnected to telephone
unilateral cleft lip closure - development of a new hybrid technique

Conditions: Complete Unilateral Cleft Lip

Summary: unilateral cleft lips can be treated with different incision techniques. according to a survey by the american cleft palate association, the millard ii technique is currently used by the majority of us cleft surgeons. in this technique, a cleft-sided advancement flap is pivoted from the cleft side into the rotation flap of the non-cleft side, which serves, among other things, to lengthen the lip. however, the rotational component is often insufficient to sufficiently lengthen the lip on the cleft side. the result is a raised red lip, a shortened edge of the philtrum or a so-called pipe-hole deformity. in order to compensate for these "deficiencies", a triangular flap is currently being formed in the area of the white roll, which is intended to provide sufficient lengthening. however, the scar of the triangular flaps runs exactly opposite to the aesthetic unit. in addition, it often provides a step formation within the white roll. knowing the weaknesses of the previous techniques, a further development of the incision was made. the rotational flap of the millard ii technique was extended by extending the incision into the columella - similar to the well-known mohler technique. the caudal part of the advancement flap of the millard ii technique was extended by a wave incision as known from the pfeifer procedure.


Eligibility criteria:
inclusion criteria: * complete unilateral cleft lip and palate exclusion criteria: -

Keywords: cleft lip cleft lip repair unilateral cleft lip
pilates method in helicopter pilots with low back pain

Conditions: Low Back Pain

Summary: the purpose of this study is to analyze the effects of an exercise program, based on the pilates method, on the low back pain and muscle fatigue of brazilian air force helicopter pilots.

methods: this is a randomized controlled trial composed by brazilian air force helicopter instructors. the volunteers will be submitted to an initial evaluation composed by painful sensation, analyzed through the numerical pain scale, disability associated with low back pain, using the roland morris disability questionnaire, and back muscle fatigue, through the ito test. the pilots will be randomly assigned to the exercise group (exercise program based on the pilates method, twice a week for 12 weeks) and control group (no intervention). after the sixth and 12th week of the beginning of the intervention program a new evaluation will be carried out, identical to the initial one.

Eligibility criteria:
inclusion criteria: * brazilian air force helicopter instructors - natal air base; * nonspecific low back pain for more than 3 months with a score of 2 or more at numerical pain rating scale. exclusion criteria: * be undergoing physiotherapeutic treatment during the study period; * corticosteroids treatment in the last two weeks; * anti-inflammatory treatment in the previous 72 hours; * have specific spinal pathologies, such as spondylitis, spondylolysis, spondylolisthesis, disc herniation with radiculopathy or those who have had spinal surgery in the last year or who have a recent history of spinal fracture.

Keywords: low back pain physiotherapy muscle fatigue
transfusion and skeletal muscle tissue oxygenation

Conditions: Anemia

Summary: the aim of the present study was to re-challenge the current data that anaemia in chronically anaemic haematology patients is not associated with low skeletal muscle sto2, and that the age of rbcs does not influence tissue responses. the investigators investigated these aspects using improved technology nirs devices, for deeper tissue penetration and removal of the superficial signal from the skin.

anaemia is state of decreased blood oxygen carrying capacity . acute anaemia is associated with increased tissue oxygen extraction . on the other hand, with chronic anaemia human body has time to at least partially adapt to decreased blood oxygen carrying capacity , . near-infrared spectroscopy (nirs) is non-invasive method to assess tissue oxygenation (sto2) and estimate tissue haemoglobin (thb) levels . the investigators have studied skeletal muscle sto2 in critically ill patients with preserved oxygen (i.e., cardiogenic shock) and with impaired oxygen extraction (i.e., septic shock) , , . in addition to measuring resting sto2, the investigators performed vascular occlusion tests to stop arterial blood flow, to estimate oxygen consumption, and at the end of the occlusion, it was also possible to estimate vascular reactivity and maximal reperfusion capability . under acute blood loss in trauma patients, the skeletal muscle sto2 measured by nirs correlates with blood haemoglobin (hb) and delivery of oxygen, and can easily detect latent stage of haemorrhagic shock . unexpectedly, chronically anaemic haematology patients with preserved oxygen extraction capability did not show low skeletal sto2 and thb index despite their severe anaemia, which is what would be predicted from normal physiological responses . it is known that there are structural and functional changes to rbcs during storage. recent study detected deleterious effects of rbc storage on microvascular responses to transfusion in stable anaemic trauma patients . the aim of the present study was to re-challenge the current data that anaemia in chronically anaemic haematology patients is not associated with low skeletal muscle sto2, and that the age of rbcs does not influence tissue responses. the investigators investigated these aspects using improved technology nirs devices, for deeper tissue penetration and removal of the superficial signal from the skin.

Eligibility criteria:
inclusion criteria: * chronic haematologic patients exclusion criteria: * pregnancy * rejection to participate

Keywords: nirs transfusion rbc
supplemental high flow oxygen to reduce infections in obese gynecological cancer patients

Conditions: Supplemental Oxygen; Gynecological Cancer; Surgical Site Infections

Summary: the incidence of surgical-site infection (ssi) and complications related to wound healing reaches 10-20% of gynecological cancer patients. each complication may dramatically prolong the hospitalization period and increase the economic burden of hospital care. appropriate wound care and tissue oxygenation are of special importance for wound healing. assuming adequate perfusion, the easiest, safest, and most effective way to improve tissue oxygenation is to increase the fraction of inspired oxygen. however, there is considerable controversy as to whether supplemental oxygen actually reduces ssi and healing-related complications as to date, there is absence of relevant data.

this study aims to investigate the prophylactic value of postoperative oxygen administration against the development of wound infections in obese gynecological oncology patients undergoing laparotomy for the treatment of endometrial or ovarian cancer. at the same time, the factors that lead to an increase in this risk will be outlined.

Eligibility criteria:
inclusion criteria: * obese (bmi\>30kg/m2) gynecological cancer patients * optimized preoperative cbc values (hemoglobin \>11g/dl, wbc 4.000-11.000 x 109/l, platelets 150,000 to 400,000 x 109/l) * in the case of neoadjuvant therapy an interval longer than three weeks between the last cycle and the operation exclusion criteria: * active immunosuppresion * preexisting infection of the abdominal wall * preexisting sepsis

Keywords: supplemental oxygen surgical site infections gynecological cancer
butyrate-enriched triglyceride and diabetes prevention

Conditions: Type 2 Diabetes; PreDiabetes; Obesity

Summary: a body of animal studies as well as observational studies in humans demonstrated that butyrate is one scfa that has pronounced positive effects on body weight control, inflammation, and insulin resistance. even though the scfa hexanoate is less researched, it has been shown to be involved in anti-inflammatory processes. of note, acute human studies showed that fibre-induced metabolic improvements are linked to higher scfa levels in the systemic circulation. it has been shown that a butyrate/hexanoate-enriched triglyceride oil enhanced systemic butyrate and hexanoate concentrations for a prolonged time. yet, it remains to be determined whether a chronic increase in circulating butyrate and hexanoate concentrations translate into long-term benefits. in this study it is hypothesized that a chronic increase of butyrate/hexanoate in the circulation may improve host metabolism and metabolic health by improving adipose tissue function, reducing systemic lipid overflow and inflammation thereby increasing peripheral insulin sensitivity in individual with overweight/obesity and prediabetes.


Eligibility criteria:
inclusion criteria: in order to be eligible to participate in this study, a subject must meet all of the following criteria: * age 20-70 years * bmi ≥ 28 and \< 40 kg/m2 * weight stable for at least 3 months * normal blood pressure (systolic blood pressure 100-140 mmhg, diastolic blood pressure 60-90 mmhg) * one or more of the following criteria to determine disturbed glucose/insulin homeostasis * fasting glucose 5.6-6.9 mmol/l * two-hour glucose of 7.8-11.1 mmol/l * homa-ir ≥ 2.2 * hba1c (5.7-6.4%) exclusion criteria: * diabetes mellitus (type 1 or 2) * cardiovascular disease: including no history or myocardial infarction, heart failure, arrhythmias * pulmonary disease: no history of chronic obstructive pulmonary disease, emphysema, bronchitis, asthma * kidney (e.g. kidney failure) or liver (e.g. cirrhosis, non-alcoholic fatty acid) malfunction * gastrointestinal disease (no inflammatory bowel disease, irritable bowel syndrome or digestive disorders) or a history of abdominal surgery (except appendectomy and cholecystectomy) * autoimmune disease * any other diseases affecting glucose and/or lipid metabolism or use of any medication that influence glucose or fat metabolism and inflammation * ongoing disease or any disease with a life expectancy ≤ 5 years * abuse of products; alcohol (\>15 units per week) and drugs, excessive nicotine use defined as \>20 cigarettes per week * regular supplementation of pre- or probiotic products, use of pre- or probiotics, antibiotics and laxatives 3 months prior to the start of the study * intensive exercise training more than three hours a week * plan to lose weight or to follow a hypocaloric diet or vegetarian diet * pregnancy
the effect of different i:e ratio on gas exchange of patients undergoing gynecologic laparoscopic surgery with trendelenburg position

Conditions: Uterine Myoma; Ovarian Cyst; Laparoscopic Gynecologic Surgery

Summary: in patients undergoing gynecologic laparoscopic surgery with trendelenburg position, the disturbance of pulmonary gas exchange frequently occurs due to high intra-abdominal pressure. the investigators tried to evaluate the effect of various inspiratory to expiratory ratio on pulmonary gas exchange by randomized controlled trial.

in patients undergoing gynecologic laparoscopic surgery with trendelenburg position, the disturbance of pulmonary gas exchange frequently occurs due to high intra-abdominal pressure. during the laparoscopic surgery with abdominal gas insufflation, gas exchange disturbance such as co2 retention, hypoxemia occurs in addition to high plateau airway pressure. the usual strategy against these kinds of problem is pressure-controlled ventilation. however, the gas exchange problem especially co2 retention can not be solved in some cases. the inverse-ratio ventilation (irv), which prolongs the inspiratory time greater than expiratory time, can be applied for adult respiratory distress syndrome. the efficacy of irv is to improve gas-exchange status by increasing mean airway pressure and alveolar recruitment. there have been several clinical investigations which applied irv during general anesthesia. however, there have been debates about the effect of irv during general anesthesia. therefore, we tried to apply the irv for subjects undergoing laparoscopic surgery, and evaluate the effect of different i:e ratio on the pulmonary gas exchange and respiratory mechanics.

Eligibility criteria:
inclusion criteria: * patients undergoing elective gynecologic laparoscopic surgery * the duration of pneumoperitoneum during laparoscopic surgery is more than 40 minutes exclusion criteria: * asa (american society of anesthesiologists) classification of the subjects more than iii. * age under 20, or more than 65 years. * past history of pneumothorax, copd, asthma. * patients with ischemic heart disease, valvular heart disease.

Keywords: laparoscopic gynecologic surgery gas exchange inspiratory time expiratory time i:e ratio
precision palliative care for patients with advanced esophageal cancer

Conditions: Esophageal Cancer

Summary: the goal of this clinical trial is to learn if precision palliative care improves survival of patients with advanced esophageal cancer in adults. researchers will compare precision palliative care and standard palliative care to see if precision palliative care works more effectively to treat advanced esophageal s cancer. participants will receive precision palliative care or standard palliative care. all participants will answer survey questions about their quality of life, mdasi, phq-9, gad-7 for 1 years.


Eligibility criteria:
inclusion criteria: 1. written informed consent 2. aged ≥18 years 3. histologically confirmed esophageal cancer 4. clinical stages iv based on the 8th ajcc tnm classification, or recurrent esophageal cancer 5. plan to treated with pd-1 immunotherapy 6. eastern cooperative oncology group(ecog) performance status: 0-2 7. adequate organ functions absolute neutrophil counts (anc) ≥1.5×109⁄l; hemoglobin (hb) ≥9g⁄dl; platelet (plt) ≥100×109⁄l; total bilirubin ≤1.5 upper limit of normal (uln); aspartate transaminase (ast) ≤2.5 uln; alanine aminotransferase (alt) ≤2.5 uln; creatinine ≤1.5 uln. exclusion criteria: 1. esophageal perforation or hematemesis 2. any active autoimmune disease or a history of autoimmune disease (such as the following, but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, pituitary inflammation, vasculitis, nephritis, hyperthyroidism and hypothyroidism (effective hormone replacement therapy excepted)) and immunosuppressive agents or systemic hormonal therapy indicated within 28 days (for adverse events of chemoradiotherapy excepted). 3. disease progression occurs within 3months after pd-1 immunotherapy. 4. allergic to macromolecular protein preparations, or to any of the ingredients in pd-1 inhibitors for injection. 5. uncontrolled heart diseases or clinical symptoms, such as: (1) new york heart association(nyha) class ii or higher heart failure; (2) unstable angina; (3) myocardial infarction within 1 year; (4)clinically significant arrhythmia requiring clinical intervention. 6. congenital or acquired immunodeficiency (such as hiv infection); active hepatitis b (hbv-dna≥104 copy number/ml) or hepatitis c (positive hepatitis c antibody, and hcv-rna is higher than the detection limit of the analytical method); active tuberculosis. 7. active infection or unexplained fever \>38.5 °c within 2 weeks before randomization (fever due to tumor excepted, according to investigator). patients with fertility reluctant to take contraceptive measures during the trial, or female patients pregnant or breastfeeding. 8. according to the investigator, other factors that may cause termination of the study. ie, other serious diseases (including mental illness) require combined treatment, family or social factors, which may affect the safety or the collection of trial data.

Keywords: precision palliative care immunotherapy pd-1